EU MDR / IVDR

Metrological traceability for IVD calibrators and control materials under ISO 17511:2020 and EU IVDR Annex I Section 9.3, covering calibration hierarchies, JCTLM resources, and common pitfalls.

When device modifications require new regulatory submissions in the US, EU, Korea, Japan, and China — FDA special 510(k), PMA supplements, EU MDR significant changes, and Asian pathways.

EU Commission's May 2026 draft Article 6 high-risk AI classification guidelines: two-path system for medical devices, consultation deadline June 23, and compliance deadlines in 2027-2028.

How Hong Kong classifies injectable dermal fillers at the borderline between medical devices, cosmetics, and medicines — and why the May 2026 GN-00 update matters for your product.

RPM device regulation: FDA classification, CMS 2026 CPT codes (99445, 99470), reimbursement rates, SaMD, EU MDR pathway, and commercialization strategy for connected monitoring devices.

Guide to EU Digital Product Passport requirements for medical devices, including ESPR scope, battery passports, UDI/EUDAMED links, standards, and timelines.

Regulatory guide to liquid biopsy and MCED tests, including FDA pathways, Breakthrough designation, companion diagnostics, EU IVDR classification, clinical evidence, and key market players.

Swissmedic 2026 PMS focus campaign guide for Class IIa, IIb, and III devices, covering PMS plans, PSURs, PMCF data, complaints, trend analysis, and preparation.

Guide to mandatory EUDAMED registration from May 28, 2026, including actor registration, UDI/device data, certificate linkage, legacy device deadlines, and action steps.

Learn when manufacturers must report device interruptions under EU MDR Article 10a, who to notify, required data, supply chain flow, and 2026 guidance.

Prepare for EU MIR Form 7.3.1, mandatory from May 1, 2026, including changes from 7.2.1, reportability fields, UDI issuing entity selection, EUDAMED XML, and vigilance updates.

Practical guide to MDR Article 59 national derogations, including when non-CE-marked devices may be authorized, how reviews work, and manufacturer strategy.

Guide to EU Reference Laboratories under IVDR Article 100 for Class D IVDs, including rollout, affected categories, performance verification, batch testing, and manufacturer preparation.

Guide to common EU MDR technical file deficiencies in Notified Body review, including clinical evidence gaps, risk management, PMS links, equivalence, and 2026/977 timelines.

How to test AI-enabled medical devices for demographic bias, validate fairness statistically, document FDA and EU submissions, and monitor post-market performance.

Build a device cybersecurity response plan covering FDA 21 CFR 806, EU MDR vigilance, CISA timelines, containment, patient safety review, and coordinated disclosure.

Write and execute verification test protocols with clear scope, acceptance criteria, sample size rationale, results, and FDA, EU MDR, and ISO 13485 alignment.

Plan regulated cybersecurity patch deployment for fielded devices under EU MDR, FDA Section 524B, and the Cyber Resilience Act, from triage to verified rollout.

Guide to the EU BtX framework under MDCG 2025-9, covering eligibility, application steps, EMA pilot benefits, FDA comparisons, and IVD implications.

Analyze MedTech Europe's May 2026 MDR/IVDR position paper, including breakthrough and orphan pathways, cybersecurity, AI, IVDR concerns, and the legislative process.